FDA Approves New Combination Therapy for Lung Cancer
October 12, 2006
The U.S. Food and Drug Administration (FDA) approved the use of Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer. This approval was based on an improvement in survival time when Avastin was added to a standard chemotherapy regimen.
Non-small cell lung cancer accounts for 75 percent of the174,400 new cases of lung cancer that are expected to be diagnosed this year. Lung cancer is the leading cause of cancer-related death in men and women.
"FDA believes it is crucial for cancer patients to have many treatment options available to them in their battle against this disease," said Richard Pazdur, M.D., Director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "With the approval of Avastin, patients with this type of lung cancer will not only have access to another treatment option, but one that has been shown in clinical trials to increase survival time."
The multi-center clinical trial supporting this approval enrolled 878 patients who had not received prior chemotherapy. The median age of the patients was 63, and 46 percent were women. The trial compared the effectiveness of Avastin plus carboplatin and paclitaxel with chemotherapy by carboplatin and paclitaxel alone. The main outcome measure of the study was duration of survival.
The median overall survival time for patients in the Avastin plus carboplatin and paclitaxel arm was 12.3 months versus 10.3 months for patients receiving only carboplatin and paclitaxel.
The most serious adverse events associated with Avastin, including some that were fatal, were gastrointestinal perforation, wound healing complications, hemorrhage, blockage of the arteries, abnormally high blood pressure, albumin deficiency in the blood and congestive heart failure. The most common adverse events in patients receiving Avastin included weakness, abdominal pain, headache, diarrhea, nausea and vomiting.
Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, was previously approved for first- or second-line treatment of patients with metastatic cancer of the colon or rectum.
Avastin is manufactured by Genentech, Inc., in South San Francisco, Calf.
Posted: October 2006